Waters Introduces New Ion-Exchange Columns for Protein Characterization

Waters Corporation introduces its new Protein-Pak™ Hi Res, Ion-Exchange (IEX) columns designed for use with Waters ACQUITY® UltraPerformance LC® (UPLC) System for the analysis of biomolecules including monoclonal antibodies, recombinant proteins, DNA/RNA, and vaccine components. These columns give biopharmaceutical manufacturers the ability to reproducibly characterize, with greater resolution and speed, various charge states of intact biomolecules. This improved monitoring capability helps manufacturers ensure high product quality and efficacy.

Waters® Protein-Pak Hi Res IEX family of columns were developed to assist in the UPLC® characterization of recombinant proteins and monoclonal antibodies found in many of today’s novel biopharmaceutical therapeutics. These non-porous, high-ligand density particles overcome the effects of protein diffusion on peak volume and resolution experienced when using traditional porous IEX particles for large molecule separations. In addition, the novel particle and surface chemistry delivers high sample loading capacities and component resolution while minimizing column fouling.

The available ion-exchange chemistries include a strong anion-exchange (quaternary ammonium, Q) and a weak strong-cation exchanger (carboxy methyl [CM] and sulfopropyl [S]), all of which are stable over a wide pH range (3-10), high salt concentrations and operating pressures via use of polymer-based particles.

Ion-exchange chromatography is a proven and important technique for assessing the charge states of biomolecules. Biomolecules are notoriously difficult to reproducibly manufacture and protein charge variances are good indicators of deamidation or glycosylation that may affect product stability and efficacy and are thus closely monitored.